FDA 510(k)

Ora-GUARD Dental Grind Guard

Número K: K150492 · 2016-02-19

Data da decisão2016-02-19

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ora-GUARD Dental Grind Guard is the device name listed in this FDA 510(k) record. The listed applicant is Bite Tech, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K150492. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ora-GUARD Dental Grind Guard?

Ora-GUARD Dental Grind Guard is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Bite Tech, Inc.. The 510(k) number is K150492.

When did Ora-GUARD Dental Grind Guard receive FDA 510(k) clearance?

Ora-GUARD Dental Grind Guard received FDA 510(k) clearance on 2016-02-19, under 510(k) number K150492.

Who is the listed applicant for Ora-GUARD Dental Grind Guard?

The FDA 510(k) record lists Bite Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ora-GUARD Dental Grind Guard?

The FDA product code for Ora-GUARD Dental Grind Guard is OBR. This falls under the Orthopedic category.

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